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Completed

NCT Number: NCT04498260

Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture

Endoscopic resection of superficial esophageal neoplasms is already a reality and presents important advantages when compared to esophagectomy as fewer complications and better quality of life. However, extensive resections can lead to difficult-to-manage stenoses. There are several therapies available in order to prevent this stenosis but, to date, there is no definition of the gold standard.

The objective of this study was to compare the use of intralesional steroid injection versus oral prednisolone after endoscopic submucosal dissection and to evaluate the stenosis rate, number of dilations to resolve the stenosis and complications.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto do Câncer do Estado de São Paulo - ICESP

São Paulo, 01246-000, Brazil

About this study

Endoscopic resection of superficial esophageal neoplasms is widely used as an alternative to esophagectomy, since it is less invasive, besides presenting good clinical results. Compared with esophagectomy, patients submitted to endoscopic resection present shorter hospitalization time, lower incidence of complications and better quality of life in the long term.

However, repair of esophageal ulcer, caused by endoscopic resection, which occupies three quarters or more of the circumference of the organ, can result in the formation of stenosis.

In the past, there was no consensus on the use of preventive therapies for esophageal stenosis after extensive ESD. However, Oliveira et al recently demonstrated through systematic review and meta-analysis that the use of these therapies reduces the rate of stenosis (40% on average), decreased the number of dilations to resolve the stenosis (8 sessions less ), Without altering the number of complications.

Theoretically, corticosteroids are the most appropriate choice due to their mechanism of action, modulating wound healing by preventing inflammation, by reducing prolyl hydroxylase, which helps reduce collagen production.

However, treatment with corticosteroids, especially at high oral doses, can cause several adverse effects, such as immunosuppression, diabetes, psychiatric disorders, osteoporosis, optic lesion and peptic ulcer. Thus, the use of local corticosteroid injection could minimize these side effects. However, local injection implies risks of bleeding and perforation, and is of limited use in patients receiving anticoagulant or antiplatelet therapy.

The objective of this study was to compare the local corticosteroid injection and the use of oral corticosteroids to prevent stenosis after extensive submucosal endoscopic resection of superficial esophageal carcinoma, in relation to the stenosis rate, number of dilations necessary to resolve the stenosis and frequency of complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a diagnosis of superficial esophageal neoplasm submitted to submucosal endoscopic resection greater than 3/4 of the organ circumference;
  • Absence of lymph node or distant metastases, evaluated through echoendoscopy, CT and PET-CT;
  • Signed informed consent form

Exclusion criteria

  • Presence of invasive esophageal neoplasia
  • Hepatical cirrhosis
  • Diabetes mellitus with fasting glycemia above 200mg%
  • Use of corticosteroids in the 30 days prior to ESD
  • INR> 1.5
  • Platelet count less than 50,000
  • Active gastrointestinal ulcer
  • Severe psychiatric illness
  • Glaucoma
  • History of allergy or hypersensitivity to corticosteroids or proton pump inhibitor

Treatment and study plan

Local steroid - triamcinolone acetonide

Drug

(triamcinolone acetonide)

Oral steroid - predonisolone

Drug

(predonisolone)

Primary outcomes

  1. Early Stenosis rate

    Time frame: 12 weeks

    Stenosis to the passage of the standard endoscopic (9.8 mm)

  2. Late Stenosis rate

    Time frame: 24 weeks

    Stenosis to the passage of the standard endoscopic (9.8 mm)

  3. Early resistance rate

    Time frame: 12 weeks

    Resistance to the passage of the standard endoscopic (9.8 mm)

  4. Late resistance rate

    Time frame: 24 weeks

    Resistance to the passage of the standard endoscopic (9.8 mm)

Secondary outcomes

  1. Number of dilations to solve the stenosis

    Time frame: 24 weeks

    Number of endoscopic dilations (Savary or balloon)

Other outcomes

  1. Complications

    Time frame: 24 weeks

    Complications related to the procedure and preventive therapy.

Sponsors and collaborators

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Other

Registry information

Official study title

Prospective, Randomized Trial of Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture After Endoscopic Submucosal Dissection

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2020
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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